Trexol Use In Pregnancy & Lactation

Effects on fertility: Methotrexate has been reported to cause impairment of fertility, defective oogenesis or spermatogenesis, oligospermia, menstrual dysfunction and amenorrhea in humans, during and for a short period after cessation of therapy.
Men treated with methotrexate should use contraception and not father a child during and for six months after treatment. Methotrexate is reported to be genotoxic and has caused increased number of abnormal and immobile spermatozoa.
Since treatment with methotrexate can lead to severe and possibly irreversible disorders in spermatogenesis, men should seek advice about the possibility of sperm preservation before starting the therapy. The possible risks of effects on reproduction should be discussed with patients of childbearing potential.
Use in pregnancy - Category D: Use of methotrexate is contraindicated throughout pregnancy. Methotrexate has been shown to be teratogenic. Methotrexate has caused embryo toxicity, abortion, foetal death and/or congenital abnormalities when administered to pregnant women.
Methotrexate is not recommended in women of childbearing potential unless there is appropriate medical evidence that the benefits are expected to outweigh the considered risks.
Women of childbearing potential should not be started on methotrexate until existing pregnancy is excluded with certainty, e.g. by pregnancy test prior to initiating therapy. Both male and female patients should be fully counselled on the serious risk to the foetus if pregnancy occurs whilst undergoing treatment.
Pregnancy should be avoided and reliable effective contraception used if either partner is receiving methotrexate, during and for a minimum of six months after therapy has ceased, although the optimal time interval between the cessation of methotrexate treatment of either partner, and pregnancy, has not been clearly established.
Teratogenicity: There is evidence of a teratogenic risk in humans (craniofacial, cardiovascular and extremital malformations) and in several animal species.
Use in lactation: Methotrexate passes into breast milk and is contraindicated during breastfeeding. Because of the potential for serious adverse reactions from methotrexate in breast fed infants, it is contraindicated in nursing mothers.